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This study is a multicenter, open-label study with both prospective and retrospective components, enrolling up to 120 subjects undergoing breast reconstruction using acellular dermal matrix (ADM).
The primary objective of this study is to evaluate differences in complication rates between the test group undergoing breast reconstruction with SC Derm and the control group undergoing breast reconstruction with other ADM products.
In South Korea, breast reconstruction using implants or autologous abdominal tissue is commonly performed to address the aesthetic and psychological needs of patients who have undergone total mastectomy for breast cancer. In such procedures, acellular dermal matrix (ADM) is used to compensate for soft tissue and skin deficits resulting from tumor resection.
This clinical study is designed to evaluate differences in clinical efficacy, aesthetic outcomes, and safety between ADM processed using supercritical carbon dioxide technology and conventional ADM products in breast reconstruction surgery.
The test group will prospectively enroll 60 patients undergoing breast reconstruction using SC Derm (an investigational ADM processed with supercritical carbon dioxide technology). The control group will retrospectively include 60 patients who underwent breast reconstruction using other ADM products, based on medical records from 2022.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Among patients scheduled for total mastectomy due to the breast cancer, Female patients aged 20 to 69 who are willing to undergo immediate breast reconstruction using implants will be enrolled. The test group will be prospectively selected in 60 patients who undergo the breast reconstruction surgery applying with SC Derm(Inverstigational ADM processed by the supercritical technology). |
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| Control Group | The control group will be retrospectively collected in 60 patients who underwent the breast reconstruction surgery applying with other ADM from the current medical records for one year of 2022. Among patients who underwent implant-based immediate breast reconstruction after total mastectomy, those who had the procedure between January 1, 2022, and December 31, 2022, and who completed at least 6 months of follow-up by June 2023 were included in the study. For this retrospective study, medical records of patients who met the inclusion and exclusion criteria were extracted. Data collection was carried out in the same manner as it would be for a prospective study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transplant acellular dermal matrix(ADM) | Biological | The principle of surgery is the pectoral muscle preservation (prepectoral) method and the subpectoral method (Breast Reconstruction using implants). After wrapping the implant with acellular dermal matrix(ADM), it is inserted into the breast and fixed to the underlying muscle or surrounding tissue depending on the situation. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Breasts by Independent Investigator Using a 5-Point Likert Scale | Cosmetic outcomes will be independently assessed by two qualified specialists based on standardized breast photographs taken preoperatively and at 6 months postoperatively. The evaluation will include breast shape, volume, symmetry, nipple-areolar complex, and scar. Each item will be scored using a 5-point Likert scale (1-5), where higher scores indicate better cosmetic outcomes:
The total score ranges from 5 to 25, with higher total scores indicating better overall cosmetic outcomes. | 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's Satisfaction Assessment | Patient self-assessment of satisfaction with surgical outcomes will be evaluated at 1 month and 6 months postoperatively. Satisfaction will be assessed using a 4-point categorical scale (1-4), as follows:
Higher scores indicate greater patient satisfaction. | Beaseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Female patients who have undergone total mastectomy due to breast cancer from three primary university hospitals.
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| Name | Affiliation | Role |
|---|---|---|
| Woojin Song, Ph.D | Soon Chun Hyang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soon Chun Hyang University Hospital | Seoul | Seoul | 04401 | South Korea |
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| Label | URL |
|---|---|
| Polotto S, Bergamini ML, Pedrazzi G, et al. One-step prepectoral breast reconstruction with porcine dermal matrix-covered implant: a protective technique improving the outcome in post-mastectomy radiation therapy setting. Gland Surg 2020;9(2):219-228. | View source |
| Hagarty SE, et al. Decreased length of postoperative drain use, parental opioids, length of stay and complication rates in patients receiving meshed versus unmeshed ADM. Plast Reconstr Surg 2020; 145(4):889-897. | View source |
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| Baker's grade of capsular contracture | The occurrence of capsular contracture will be assessed clinically at the same follow-up visits (1 month and 6 months post-surgery). Grade I: Breast is normally soft and appears natural Grade II: Breast is a little firm but appears normal Grade III: Breast is firm and appears abnormal Grade IV: Breast is hard, painful, and appears abnormal | 6 months after surgery |
| Complication Assessment | Evaluate the frequency and incidence rate of most commonly occurred complications of infection, skin necrosis, seroma, hematoma, implants removal. | from the operation day to 6 months after surgery |
| Viezel-Mathieu A, Alnaif N, Aljerian A, et al.Acellualr dermal matrix-sparing direct-to-implant prepectoral breast reconstruction: A comparative study including cost analysis. Ann Plast Surg 2020;84(2):139-143. | View source |
| Nam SY, Youn D, Kim GH, et al. In vitro characterization of a novel human acellular dermal matrix (BellaCell HD) for breast reconstruction. Bioengineering (Basel) 2020;7(2):39. | View source |
| Heath, D.E. A Review of Decellularized Extracellular Matrix Biomaterials for Regenerative Engineering Applications. Regen. Eng. Transl. Med. 2019;5;155-166. | View source |
| Seo Y, Jung Y, Kim SH. Decellularized heart ECM hydrogel using supercritical carbon dioxide for improved angiogenesis. Acta Biomater. 2018; 67:270-281 | View source |
| Srivastava V, Basu S, Shukla VK. Seroma formation after breast cancer surgery: what we have learned in the last two decades. J Breast Cancer. 2012;15(4):373-380 | View source |
| Sforza M, Husein R, Atkinson C, Zaccheddu R. Unraveling Factors Influencing Early Seroma Formation in Breast Augmentation Surgery. Aesthet Surg J. 2017 Mar 1;37(3):301-307. | View source |
| A retrospective review of breast reconstruction outcomes comparing AlloDerm and DermaCELL. Heather Greig, Janine Roller, William Ziaziaris, Nancy Van Laeken. JPRAS Open, 2019 Jul;22:19-26 | View source |